search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


SL-PLUS, FEMORAL STEM. A PROSPECTIVE, RANDOMIZED, SINGLE CENTER, CLINICAL STUDY OF THE SL-PLUS FEMORAL STEM (Standard versus HA coated) IN TOTAL HIP REPLACEMENT


- candidate number24288
- NTR NumberNTR5844
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-apr-2016
- Secondary IDsNL23524.048.08 
- Public TitleSL-PLUS, FEMORAL STEM. A PROSPECTIVE, RANDOMIZED, SINGLE CENTER, CLINICAL STUDY OF THE SL-PLUS FEMORAL STEM (Standard versus HA coated) IN TOTAL HIP REPLACEMENT
- Scientific TitleSL-PLUS, FEMORAL STEM. A PROSPECTIVE, RANDOMIZED, SINGLE CENTER, CLINICAL STUDY OF THE SL-PLUS FEMORAL STEM (Standard versus HA coated) IN TOTAL HIP REPLACEMENT
- ACRONYM
- hypothesisThe primary objective is the investigation early migration of the SL-PLUS stem measured by means of Roentgen Stereophotogrammetric Analysis (RSA). Migration is assessed with regard to translation (x, y and z direction) and rotation. Early migration will be compared between the HA-coated SL-PLUS stem (Study group) and the standard SL-PLUS stem (control group). H0: Total migration in the HA-coated group is equal or more compared to the migration in the non-HA coated group. H1: Total migration in the HA-coated group is less than in the non-HA-group.
- Healt Condition(s) or Problem(s) studiedHip, Prothesis, X-ray
- Inclusion criteria- Patients with primary osteoarthritis, avascular necrosis, femoral neck fracture, or hip dysplasia
- Patients requiring primary arthroplasty
- Age at time of surgery: 60-75
- Both male and female
- Patients capable of giving informed consent and expressing a willingness to comply with the post-operative review program
- Exclusion criteria- Post-traumatic OA (proximal femur fracture)
- Post-infection in respective joint
- Prior osteotomy of the affected hip
- Patients under treatment for osteoporosis (with bisphosphonate)
- OA patients diagnosed Charnley C
- Patients requiring cortisone medication
- Patients whose body mass index is higher than 35
- Patients already participating in the RSA hip study.
- The individual is unable or unwilling to sign the patient informed consent specific to this study
- Patients requiring revision arthroplasty
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 12-feb-2009
- planned closingdate15-dec-2017
- Target number of participants52
- InterventionsTotal hip arthroplasty with either a standard or a hydroxyapatite coated stem.
- Primary outcomeRSA migration during the first 5 years of follow up
- Secondary outcomeHarris Hip Score
HOOS Pain and ADL domains
- TimepointsPre-operative, direct postoperative, 6 weeks, 3 months, 6 months, 12 months, 2 years and 5 years.
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDr. D. Haverkamp
- CONTACT for SCIENTIFIC QUERIESDr. D. Haverkamp
- Sponsor/Initiator MC Slotervaart
- Funding
(Source(s) of Monetary or Material Support)
None
- PublicationsN/A
- Brief summaryAn ongoing discussion is whether using a hydroxy-apatite coating enhances the ingrowth and longevity of a femoral stem in total hip arthroplasty. The best way to predict speed of ingrowth and long-term outcome is by performing a radiostereometric analysis study. In order to study the effect of hydroxyapatite (HA) coating on the migration of the SL-PLUS hip stem, a single center RSA, prospective double blind randomized controlled trial is being conducted. The primary objective is to investigate the early migration of the hydroxyapatite (HA)-coated SL-PLUS stem compared to the Standard (non-coated) SL-PLUS stem by means of RSA.
- Main changes (audit trail)Trial registered on website after recruitment is closed-EB
- RECORD21-apr-2016 - 28-jun-2016


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl